The Food and Drug Administration (FDA) issued a final rule to revise the type size requirements for front-of-pack (FOP) calorie declarations that are used to comply with the vending machine calorie labeling requirements. The final rule requires such calorie declarations to be at least 150 percent the size of the net quantity of contents statement as required under 21 C.F.R. § 101.7(i) (i.e., 1.5 x the size of the net weight). FDA proposed this change to the type size requirements in July 2018, after industry expressed concerns that the previous type size requirement for FOP calorie declarations – at least 50 percent of the size of the largest printed matter on the label – was impractical, needlessly burdensome, and would disrupt existing voluntary industry front-of-pack nutrition labeling programs. The compliance date for the new font size requirement is July 1, 2021. FDA also announced it will continue its enforcement discretion with respect to the vending machine labeling requirements as applied to gums, mints, and roll candy products sold in glass-front machines in packages that are too small to bear FOP labeling.

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On October 21, 2019, the U.S. Food and Drug Administration (FDA) held a public meeting to engage stakeholders on the agency’s initiative, “A New Era of Smarter Food Safety,” to build on the advances that have been and are being made in FDA’s implementation of the FDA Food Safety Modernization Act (FSMA).1 FDA will use input from the meeting and written comments to the docket to develop a Blueprint for a New Era of Smarter Food Safety, which the agency plans to release in early 2020. The Blueprint will outline the agency’s vision for a modern approach to food safety that includes technology-enabled traceability and the use of predictive analytic tools to assess risk and set agency priorities. FDA has opened a docket for written comments, which are due by November 20, 2019.2 The specific questions on which FDA has requested input are included as an appendix to this memo and provide insight into FDA’s current thinking on these issues. The discussion below provides a high-level summary of the agency statements and stakeholder comments made during the meeting.

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Today, the U.S. Food and Drug Administration (FDA) updated its “Industry Resources on the Changes to the Nutrition Facts Label” webpage questions and answers,1 stating that the agency does not intend to take enforcement actions related to the new nutrition labeling requirements for the first six months following the January 1, 2020 compliance date for businesses with more than $10 million in annual food sales.2 FDA explains that it has received several requests for additional time to comply with the new nutrition labeling requirements, and accordingly intends to work cooperatively with industry for the first 6 months following the compliance date:

I understand that the FDA has received multiple requests from manufacturers to provide additional time to comply with the new requirements. Do I still have to meet the January 1, 2020, compliance date?

The FDA has heard from several manufacturers and groups that more time may be needed to meet all of the requirements. Therefore, during the first 6 months following the January 1, 2020, compliance date, FDA plans to work cooperatively with manufacturers to meet the new Nutrition Facts label requirements and will not focus on enforcement actions regarding these requirements during that time.

The agency statement provides the industry with much-needed flexibility to facilitate a seamless transition to the new labels. We would encourage companies to maintain their diligence in transitioning to the new labels so that the entire inventory will be transitioned during the first six months of 2020. We will continue to monitor the FDA’s implementation of the new nutrition labeling requirements. If you have questions on this or any other matter, please contact us.


1 See Industry Resources on Changes to the Nutrition Facts Label, available at https://www.fda.gov/food/food-labelingnutrition/ industry-resources-changes-nutrition-facts-label#Compliance.
2 For more information on the compliance date for the nutrition labeling final rules, see our memo, available at https://www.hlfoodlaw.com/wp-content/uploads/sites/357/2018/05/HL-Memo-FDA-Finalizes-Extension-of-Compliance-Date-for-Nutrition-Labeling-Final-Rules.pdf. For manufacturers with less than $10 million in annual food sales, the compliance date is January 1, 2021.

On October 10, 2019, the Draft Amendment to the Mexican Official Standard NOM-051-SCFI/SSA1-2010, General Labelling Specifications for Prepackaged Foods and Non-Alcoholic Beverages-Commercial and Health Information (NOM-051) was published in the Federal Official Gazette (DOF).

The aforementioned publication derives from the amendment process which is subject to the referred Mexican Official Standard. As part of such process, any individuals and/or stakeholders have a 60 calendar-day period for the submission of any comments regarding the contents of the draft amendment to the NOM-051, before the National Advisory Committee on Standardization of the Ministry of Economy (CCNNSE, by its initials in Spanish).

Upon the conclusion of the period, the CCNNSE shall analyze all the comments received and, if applicable, it shall modify the Draft Amendment to the NOM-051 within a period which shall not exceed 45 calendar days.

Subsequently, the answers to the individuals’ comments and, where applicable, the modifications to the Draft Amendment to the NOM-051 shall be published in the DOF, at least 15 calendar days prior to the date when the publication of the Mexican Official Standard NOM-051 intends to be published in the DOF for becoming into force.

The Draft Amendment to the NOM-051 that was published last Friday is aligned with the publication that was made in the website of the National Commission for Regulatory Improvement, last October 7 in terms of the draft amendment, the following shall be emphasized:

i. It introduces new applicable terms and definitions, such as sugar added and sugar-free, natural or artificial sweetener, front labeling system; supplementary nutrition facts, children, critical nutrient, genuine and substitute products, warning stamp, among others.

ii. It now forbids the use of legends, which refer to recommendations or endorsements by professional companies or associations.

iii. The use of characters, drawings, celebrities, gifts, offers, toys, or contests is now forbidden for certain product categories.

iv. Likewise, the new draft amendment now limits the advertising of certain product categories in social media.

v. New rules apply for the use and declaration of the denomination of foods, mainly in terms of genuine and substitute products.

vi. Furthermore, the draft amendment sets out new guidelines for the declaration of ingredients, among which, the following stand out:

  • Declaration of sugars, their categories, and quantities.
  • Declarations of allergens and ingredients that may cause hypersensitivity and/or intolerance, including new categories (e.g. syrups).
  • Tighter regulations for additives.

vii. Draft amendments introduce the obligation to declare added sugars and trans-fats as part of the Nutritional Declaration of products.

viii. It now broadens the supplementary nutritional facts chapter.

ix. Adopts the Front Labeling System,  the purpose of which is to warn and inform the consumer regarding such nutrients which, pursuant to the provisions of the NOM, constitute a health risk. For example:

  • The use of warning stamps in connection to nutrients (for example: “Excess Calories”).
  • The use of warning stamps in connection to sweeteners (for example: “It contains sweeteners, it should be avoided in children”).
  • Precautionary legends (for example: “It contains caffeine, it should be avoided in children”).

x. Finally, the draft amendment provides for a Conformity Assessment Procedure, and now introduces the obligation to obtain the relevant compliance opinion.

The Hogan Lovells Global Regulatory team is ready to assist you and clarify any questions you have on this matter.

The U.S. Food and Drug Administration (FDA) has launched two new online dashboards that track key metrics reflecting the impacts from the FDA Food Safety Modernization Act (FSMA) regulations. The dashboards are part of FDA-TRACK, an agency-wide performance management program. There are separate dashboards for: (1) Preventive Controls and Current Good Manufacturing Practice (CGMP) Measures, and (2) Imported Food Safety Measures.

The release of these new data dashboards is consistent with one of FDA’s longstanding goals for FSMA implementation: to establish and analyze metrics to track the outcomes for the FSMA regulations. FDA’s intends to eventually release data tracking compliance with all seven major FSMA rules. This memorandum provides an overview of the information included in the two new dashboards and identifies some of the key takeaways from the data currently available.

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On September 27, 2019 the U.S. Food and Drug Administration (FDA) hosted a public meeting to gather information from stakeholders on changes the agency could make to existing standards of identity (SOIs), particularly changes that could be made across categories of standardized foods (i.e., “horizontal” changes), to provide flexibility for the development of healthier foods and facilitate innovation. Though FDA primarily was in listening mode during the meeting, comments by agency representatives suggested FDA’s commitment to SOI modernization. In particular, the agency encouraged stakeholder comments to the docket, indicating interest in highly-detailed proposals for establishing horizontal approaches to SOIs that eliminate barriers to improvements in product nutrition profiles, spur innovation, and provide flexibility to allow emerging technology to reach consumers while ensuring sufficient transparency. Written comments are due by November 12, 2019, and can be submitted to FDA docket number FDA-2018-N-2381-1371. This memorandum provides a high-level summary of the agency statements and stakeholder comments made during the meeting.

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On September 26, 2019, the Federal Trade Commission’s (FTC’s or the Commission’s) Bureau of Consumer Protection (BCP) held a public workshop on “Made in USA” and similar U.S.-origin claims for consumer goods sold in the United States. This is the first time the Commission has sought public input on its approach to such claims since issuing its 1997 Enforcement Policy Statement. The FTC is considering revising the Policy Statement or issuing formal rulemaking, and is seeking comments on consumer perception of “Made in USA” claims, the workability of the current standard, the value of a bright-line rule for the amount of permissible foreign content (e.g., a specific percentage), and its approach to enforcement, which currently emphasizes counseling compliance over prosecuting violations.

The workshop featured panelists representing members of industry, consumer advocacy groups, and FTC attorneys who are principally responsible for enforcing the Commission’s policy on “made in USA” claims. There were three discussion segments: (1) Consumer Perception – How Do Consumers Interpret Made in USA Claims; (2) Doing Business Under the Current Policy – What Are the Compliance or Policy Challenges Under the Current Framework; and (3) Enforcement Approaches – Should the Commission Reexamine Its Current Approach to Addressing Deceptive Made in USA Claims. Members of the public were not invited to speak during the workshop, but are encouraged to submit comments to the FTC docket. The FTC is requesting comments on 15 specific questions, attached in Appendix A.

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The U.S. Food and Drug Administration (“FDA”) recently released Chapter 14 of its Draft Guidance for Industry, “Hazard Analysis and Risk-Based Preventive Controls for Human Food” (“Draft Guidance”). Entitled “Recall Plans,” the chapter explains how food facilities subject to the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food Rule (“PCHF Rule”) can establish and implement a written recall plan. This memorandum provides a brief overview of the Draft Guidance. Comments on the Draft Guidance should be submitted by February 4, 2020.

Background

Facilities covered by the PCHF Rule are required to have a written recall plan if they have any foods with a “hazard requiring a preventive control,” as determined based on their hazard analysis. The regulations require the recall plan to include procedures that describe the steps to be taken, and assign responsibility for taking those steps, for the following actions, as appropriate to the facility:

  1. Directly notify the direct consignees of the food being recalled, including how to return or dispose of the affected food;
  2. Notify the public about any hazard presented by the food when appropriate to protect public health;
  3. Conduct effectiveness checks to verify that the recall is carried out; and
  4. Appropriately dispose of recalled food—e.g., through reprocessing, reworking, diverting to a use that does not present a safety concern, or destroying the food.

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On October 7th, 2019, the Regulatory Impact Analysis and the draft amendment of the Official Mexican Standard NOM-051-SCFI/SSA1-2010 – “General Labelling Specifications for Pre-packaged Foods and Non-Alcoholic Beverages – Commercial and Health Information” were published in the portal of the National Commission on Regulatory Improvement. The foregoing was the result of the proposal for amendment of the General Health Law in terms of the front labeling warnings, submitted by the Health Commission of the House of Representatives.

Below please find some of the main modifications included in the aforementioned draft amendment:

i. It introduces new applicable terms and definitions, such as sugar added and sugar-free, natural or artificial sweetener, front labeling system; supplementary nutrition facts, children, critical nutrients, genuine and substitute products, warning stamp, among others.

ii. It now forbids the use of legends which refer to recommendations or endorsements by professional companies or associations.

iii. The use of characters, drawings, celebrities, gifts, offers, toys or contests is now forbidden for certain product categories.

iv. Likewise, the new draft amendment now limits the advertising of certain product categories in social media.

v. New rules apply for the use and declaration of the denomination of foods, mainly in terms of genuine and substitute products.

vi. Furthermore, the draft amendment sets out new guidelines for the declaration of ingredients, among which the following stand out:

  • Declaration of sugars, their categories, and quantities.
  • Declarations of allergens and ingredients which may cause hypersensitivity and/or intolerance, including new categories thereof (e.g. syrups).
  • Tighter regulations for additives.

vii. Draft amendments introduce the obligation to declare added sugars and trans-fats, as part of the Nutritional Declaration of products.

viii. It now broadens the supplementary nutritional facts chapter.

ix. Adopts the Front Labeling System, the purpose of which is to warn and inform the consumer regarding nutrients which, according to the provisions of the Official Mexican Standards (NOM), constitute a health risk. For example:

  • The use of warning stamps in connection with nutrients (for example: “Excess Calories”).
  • The use of warning stamps in connection with sweeteners (for example: “It contains sweeteners, should be avoided for children”).
  • Precautionary legends (for example: “It contains caffeine, should be avoided in children”).
  1. Finally, the draft amendment provides for a Conformity Assessment Procedure, and now introduces the obligation to obtain a compliance opinion.

The Hogan Lovells Global Regulatory team is ready to assist you and clarify any questions you have on this matter.

The U.S. Food and Drug Administration (FDA) recently published a list of the records that importers are required to develop and maintain under the Foreign Supplier Verification Program (FSVP) regulation. [1] The thirteen-page document contains detailed checklists of the required records,, though not every record on the list will be applicable to every importer.  These records need to be made available to FDA during an FSVP inspection. [2]

As background, the FSVP regulation requires importers to verify that the food they are importing into the United States has been produced in a manner that meets applicable U.S. food safety standards.  To do this, importers are required to develop, implement, and maintain an FSVP that includes documentation of verification activities for each imported food from each foreign supplier. [3]  The FSVP regulation itself does not include a list of the specific records that are required to be maintained.  (In contrast, the supply-chain program component of the Preventive Controls for Human Food (PCHF) regulation does include a list of required records.)

The new list issued by FDA is highly-detailed and should be a useful tool for importers.  Likewise, this list could become a roadmap, of sorts, for FDA investigators during inspections.  FDA is actively enforcing the FSVP regulation and routinely requests that importers provide copies of all FSVP records related to the import entry that is the focus of the inspection.  Accordingly, importers may want to consider using this list to guide an internal inspection-readiness audit, or to assist with the development of their FSVP if they do not already have one.


[1]/         FDA Publishes List of Records Required Under FSVP (October 7, 2019) (FDA Constituent Update), https://www.fda.gov/food/cfsan-constituent-updates/fda-publishes-list-records-required-under-fsvp.
[2]/         Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP) Regulation Records Requirements, https://www.fda.gov/media/131229/download.
[3]/         21 CFR § 1.500 et seq.